K180349 is an FDA 510(k) clearance for the AssureTech Panel Dip Tests, AssureTech Quick Cup Tests. This device is classified as a Test, Amphetamine, Over The Counter (Class II - Special Controls, product code NFT).
Submitted by Assure Tech. (Hangzhou) Co, Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on April 5, 2018, 56 days after receiving the submission on February 8, 2018.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3100.
| 510(k) Number | K180349 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 2018 |
| Decision Date | April 05, 2018 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | NFT - Test, Amphetamine, Over The Counter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3100 |